Understanding Health-Related Quality of Life Measurement

Measuring Health-Related Quality of Life Ron D. Hays, Ph.D. UCLA Department of Medicine UCLA School of Public Health RAND Health Program May 13, 2015, 8-9:50am (M218, 41-268)

Students Aryana Amoon, Epidemiology Shannon Dunlap, Social Welfare Nancy Guerrero-Llamas, Comm. Health Sci. Aryun Hahm, Social Welfare Melissa Johnson, Nursing Neha Srivastava, Social Welfare Leslie Thomas, Community Health Sciences Lumo Tserling, Visiting student from Tibet

U.S. Health Care Issues ACE Signs Access to care ~ 50 million people without health insurance Costs of care Expenditures ~ $ 2.7 Trillion Effectiveness (quality) of care 3

How Do We Know If Care Is Effective? Effective care maximizes probability of desired health outcomes Health outcome measures indicate whether care is effective Cost Effectiveness 4

Indicators of Health Signs and Symptoms of Disease 5

Indicators of Health Signs and Symptoms of Disease Functioning Well-Being 6

Health-Related Quality of Life (HRQOL) How the person FEELs (well-being) Emotional well-being Pain Energy What the person can DO (functioning) Self-care Role Social 7

Indicators of Health Signs and Symptoms of Disease Functioning Well-Being 8

KDQOL Symptoms/Problems During the past 4 weeks, to what extent were you bothered by each of the following? Soreness in your muscles? Chest pain? Itchy skin? Shortness of breath? Faintness or dizziness? 9

Health-Related Quality of Life (HRQOL) Quality of environment Type of housing Level of income Social Support 10

Determinants of Health Quality Of Care Health Characteristics Behavior Environment Chronic Conditions 11

Patient-Reported Measures (PRMs) Mediators Health behaviors (adherence) Health Care Process Reports about care (e.g., communication) Outcomes (PROs) Patient satisfaction with care Health-Related Quality of Life (HRQOL) 12

Type of HRQOL Scores Multiple Scores (Profile) Generic (SF-36) How much of the time during the past 4 weeks have you been happy? (None of the time All of the time) Targeted ( Disease specific ) KDQOL-36 My kidney disease interferes too much with my life. Single Score Preference-based (EQ-5D, HUI, SF-6D) Combinations of above 13

HRQOL Scoring Options 0-100 possible range T-scores (mean = 50, SD = 10) (10 * z-score) + 50 z-score = (score mean)/SD 0 (dead) to 1 (perfect health) 14

HRQOL in HIV Compared to other Chronic Illnesses and General Population Emot. Phy func MS ESRD Diabetes Depression Prostate disease GERD Epilepsy General Pop AIDS Symptomatic Asymptomatic 0 10 20 30 40 50 60 T-score metric 15 Hays et al. (2000), American Journal of Medicine

HRQOL in HIV Compared to other Chronic Illnesses and General Population Emot. Phy func MS ESRD Diabetes Depression Prostate disease GERD Epilepsy General Pop AIDS Symptomatic Asymptomatic 0 10 20 30 40 50 60 T-score metric 16 Hays et al. (2000), American Journal of Medicine

HRQOL in HIV Compared to other Chronic Illnesses and General Population Emot. Phy func MS ESRD Diabetes Depression Prostate disease GERD Epilepsy General Pop AIDS Symptomatic Asymptomatic 0 10 20 30 40 50 60 T-score metric 17 Hays et al. (2000), American Journal of Medicine

HRQOL in HIV Compared to other Chronic Illnesses and General Population Emot. Phy func MS ESRD Diabetes Depression Prostate disease GERD Epilepsy General Pop AIDS Symptomatic Asymptomatic 0 10 20 30 40 50 60 T-score metric 18 Hays et al. (2000), American Journal of Medicine

Item Responses and Trait Levels Person 1 Person 2 Person 3 Trait Continuum Item 1 Item 2 Item 3 www.nihpromis.org 19

In general, how would you rate your health? Excellent Very Good Good Fair Poor 21

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In general, how would you rate your health? 62 = Excellent 54 = Very Good 47 = Good 38 = Fair 29 = Poor Reliability = 0.52 (compared to 0.81 for 4-item scale). 23

Reliability Target for Use of Measures with Individuals Reliability ranges from 0-1 0.90 or above is goal SE = SD (1- reliability)1/2 Reliability = 1 (SE/10)2 Reliability = 0.90 when SE = 3.2 95% CI = true score +/- 1.96 x SE 24

In the past 7 days I was grouchy [1st question] Never [39] Rarely [48] Sometimes [56] Often [64] Always [72] Estimated Anger = 56.1 SE = 5.7 (rel. = 0.68) 25

In the past 7 days I felt like I was ready to explode [2nd question] Never Rarely Sometimes Often Always Estimated Anger = 51.9 SE = 4.8 (rel. = 0.77) 26

In the past 7 days I felt angry [3rd question] Never Rarely Sometimes Often Always Estimated Anger = 50.5 SE = 3.9 (rel. = 0.85) 27

In the past 7 days I felt angrier than I thought I should [4th question] - Never Rarely Sometimes Often Always Estimated Anger = 48.8 SE = 3.6 (rel. = 0.87) 28

In the past 7 days I felt annoyed [5th question] Never Rarely Sometimes Often Always Estimated Anger = 50.1 SE = 3.2 (rel. = 0.90) 29

In the past 7 days I made myself angry about something just by thinking about it. [6th question] Never Rarely Sometimes Often Always Estimated Anger = 50.2 SE = 2.8 (rel = 0.92) 30

PROMIS Physical Functioning vs. Legacy Measures 10 20 30 40 50 60 70 31

Is CAM Better than Standard Care (SC)? 100 90 80 CAM 70 SC 60 CAM 50 SC 40 30 20 10 0 Physical Health Mental Health CAM > SC SC > CAM 32

Is Acupuncture Related to Worse HRQOL? Subject Acupuncture General Health 1 2 3 4 5 6 7 8 9 No No No No No Yes Yes Yes Yes Yes dead dead 50 60 70 40 50 50 55 55 10 Group n HRQOL No Acupuncture Yes Acupuncture 3 5 60 50 33

http://www.ukmi.nhs.uk/Research/pharma_res.asp 34

0.435 35

HRQOL in SEER-Medicare Health Outcomes Study (n = 126,366) Controlling for age, gender, race/ethnicity, education, income, and marital status. 36

Physical Functioning and Emotional Well-Being at Baseline for 54 Patients at UCLA-Center for East West Medicine EWB Physical MS = multiple sclerois; ESRD = end-stage renal disease; GERD = gastroesophageal reflux disease. 37 37

Significant Improvement in all but 1 of SF-36 Scales (Change is in T-score metric) Change t-test prob. PF-10 RP-4 BP-2 GH-5 EN-4 SF-2 RE-3 EWB-5 PCS MCS 1.7 4.1 3.6 2.4 5.1 4.7 1.5 4.3 2.8 3.9 2.38 3.81 2.59 2.86 4.33 3.51 0.96 3.20 3.23 2.82 .0208 .0004 .0125 .0061 .0001 .0009 .3400 .0023 .0021 .0067 38

Effect Size (Follow-up Baseline)/ SDbaseline Cohen s Rule of Thumb: ES = 0.20 Small ES = 0.50 Medium ES = 0.80 Large 39

Effect Sizes for Changes in SF-36 Scores Effect Size 50 0.53 0.36 0.13 0.35 0.35 0.21 0.11 0.41 0.24 0.30 45 40 35 30 25 Baseline 20 Followup 15 10 5 0 PFI Role-P Pain Gen H Energy Social Role-E EWB PCS MCS PFI = Physical Functioning; Role-P = Role-Physical; Pain = Bodily Pain; Gen H=General Health; Energy = Energy/Fatigue; Social = Social Functioning; Role-E = Role-Emotional; EWB = Emotional Well-being; PCS = Physical Component Summary; MCS =Mental Component Summary. 40

Defining a Responder: Reliable Change Index (RCI) X X 2 1 ( 2 ( ) ) SEM = 1 SEM SD r bl xx Note: SDbl= standard deviation at baseline rxx = reliability 41

Amount of Change in Observed Score Needed To be Statistically Significant ( 2 (SD ) ) r - (1 (1.96) ) bl xx Note: SDbl= standard deviation at baseline and rxx = reliability 42

Amount of Change in Observed Score Needed for Significant Individual Change Scale RCI Effect size Cronbach s alpha PF-10 8.4 0.67 0.94 RP-4 8.4 0.72 0.93 BP-2 10.4 1.01 0.87 GH-5 13.0 1.13 0.83 EN-4 12.8 1.33 0.77 SF-2 13.8 1.07 0.85 RE-3 9.7 0.71 0.94 EWB-5 13.4 1.26 0.79 PCS 7.1 0.62 0.94 MCS 9.7 0.73 0.93 43 43

Amount of Change Needed for Significant Individual Change Effect Size 1.33 1.07 0.67 0.72 1.01 1.13 0.71 1.26 0.62 0.73 PFI = Physical Functioning; Role-P = Role-Physical; Pain = Bodily Pain; Gen H=General Health; Energy = Energy/Fatigue; Social = Social Functioning; Role-E = Role-Emotional; EWB = Emotional Well-being; PCS = Physical Component Summary; MCS =Mental Component Summary. 44

7-31% of People in Sample Improve Significantly % Improving % Declining Difference PF-10 RP-4 13% 31% 2% 2% + 11% + 29% BP-2 22% 7% + 15% GH-5 EN-4 SF-2 RE-3 EWB-5 PCS 7% 9% 17% 15% 19% 24% 0% 2% 4% 15% 4% 7% + 7% + 7% + 13% 0% + 15% + 17% MCS 22% 11% + 11% 45

Thank you. drhays@g.ucla.edu Powerpoint file at: http://gim.med.ucla.edu/FacultyPages/Hays/ 46

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